Cleared Traditional

DSL ACTIVE AFP ELISA, MODEL DSL-10-8400

K990138 · Diagnostic Systems Laboratories, Inc. · Immunology
Jun 1999
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K990138 is an FDA 510(k) clearance for the DSL ACTIVE AFP ELISA, MODEL DSL-10-8400, a Kit, Test,alpha-fetoprotein For Testicular Cancer (Class II — Special Controls, product code LOJ), submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on June 21, 1999, 153 days after receiving the submission on January 19, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K990138 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 1999
Decision Date June 21, 1999
Days to Decision 153 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LOJ — Kit, Test,alpha-fetoprotein For Testicular Cancer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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